Suppliers and packagers for kisqali

kisqali

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0860-01	1 BLISTER PACK in 1 CARTON (0078-0860-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK	2017-03-13
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0867-42	3 BLISTER PACK in 1 CARTON (0078-0867-42) / 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)	2017-03-13
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0874-63	3 BLISTER PACK in 1 CARTON (0078-0874-63) / 21 TABLET, FILM COATED in 1 BLISTER PACK (0078-0874-21)	2017-03-13

Suppliers for the Pharmaceutical Drug: KISQALI

Last updated: July 29, 2025

Introduction

KISQALI (ribociclib) is an oral CDK4/6 inhibitor developed by Novartis, primarily used in the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. As a targeted cancer therapy, KISQALI’s manufacturing relies on a complex supply chain involving multiple suppliers across different stages of production, including active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution. Understanding the supplier network behind KISQALI is critical for stakeholders—pharmaceutical companies, investors, healthcare providers, and policymakers—to assess supply security, potential risk factors, and the overall market landscape.

Active Pharmaceutical Ingredient (API) Suppliers

The core component of KISQALI is its active pharmaceutical ingredient (API). Novartis’s proprietary API synthesis process for ribociclib relies on specialized chemical synthesis, which requires sourcing high-purity raw materials, intermediates, and catalysts from specialized chemical suppliers.

While Novartis has not publicly disclosed all of its API raw material suppliers, industry sources and regulatory disclosures suggest multiple tiers of suppliers contribute to the API production:

• Chemical Raw Material Suppliers: These companies provide key starting materials, intermediates, and reagents necessary for API synthesis. Large chemical suppliers such as BASF, Dow, Evonik, and Lanxess are typical providers of quality raw materials for active pharmaceutical ingredients globally. Their involvement ensures the consistency and compliance of the API with regulatory standards.

• Specialty Chemical Suppliers: Companies like Sigma-Aldrich (part of Merck Group) and Alfa Aesar supply specialized chemical reagents, catalysts, and solvents used in API manufacturing. These suppliers support the fine chemical requirements of CDK4/6 inhibitor synthesis.

• Contract Manufacturing Organizations (CMOs): Novartis collaborates with strategic CMOs and outsourced suppliers to produce the API at scale, especially during high demand or manufacturing capacity expansion. Although specific CMO names remain undisclosed, large players such as Thermo Fisher Scientific and Vetter are known to handle API synthesis or intermediates for similar medications.

Formulation and Finished Product Suppliers

• Fill-Finish and Packaging: The final KISQALI formulation is filled into blister packs or bottles at pharmaceutical manufacturing facilities. Novartis operates its own manufacturing sites, primarily in Switzerland and India, or partners with CMOs for these processes:

  • Novartis’s manufacturing plants in Stein, Switzerland, are responsible for filling and packaging KISQALI.

  • Indian pharmaceutical manufacturing plants, notably in Hyderabad and Visakhapatnam, have been involved in generic production and may supply certain formulations.

• Distribution Partners: Once produced, KISQALI is distributed globally via Novartis's extensive distribution network, which includes third-party logistics providers and distribution partners like Morris Veterinary and McKesson in the US, and Alliance Healthcare in Europe.

Regulatory and Quality Assurance

Suppliers are vetted through compliance with regulatory standards, including current Good Manufacturing Practices (cGMP) mandated by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency of Japan).

Manufacturers must also meet ICH guidelines for chemicals and pharmaceuticals to ensure API quality, purity, and potency.

Supply Chain Challenges and Risks

The KISQALI supply chain faces potential risks like raw material shortages, geopolitical disruptions, regulatory compliance issues, and capacity constraints:

• Raw Material Availability: Disruptions in the supply of key intermediates can delay production. For example, global shortages in certain chemicals or geopolitical conflicts affecting raw material imports could impact API production.

• Manufacturing Capacity: Increased demand as KISQALI gains broader indications or markets can strain existing manufacturing capacity. Novartis’s strategy involves multiple API production sites with redundancies for supply security.

• Regulatory Changes: Changes in regulatory standards or quality requirements could impact existing suppliers or necessitate qualification of new partners.

Market Dynamics and Supplier Strategy

Novartis’s supplier strategy emphasizes diversification to mitigate risks associated with sole-source dependencies. The company actively engages multiple suppliers and partners to ensure uninterrupted API supply. Collaborating with established chemical producers supports supply chain resilience, while investment in manufacturing capacity expansion ensures future demand can be met.

Conclusion

The supplier network for KISQALI encompasses a broad ecosystem of chemical raw material providers, specialty chemical suppliers, contract manufacturers, and logistic partners. While Novartis maintains control over core manufacturing processes, reliance on multiple suppliers for raw materials and intermediates forms a critical component of its supply security. The ongoing diversification of supplier relationships and manufacturing capacity expansion reflects a proactive approach to risks inherent in complex pharmaceutical manufacturing.

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Key Takeaways

• Diverse Supplier Network: KISQALI’s supply chain involves multiple chemical suppliers for raw materials, specialty chemicals, and manufacturing partners for APIs and formulation.

• Strategic Manufacturing Locations: Novartis leverages manufacturing facilities in Switzerland and India, balancing quality standards and capacity needs.

• Supply Risks: Raw material shortages, geopolitical issues, and capacity constraints pose potential risks; diversification strategies mitigate these factors.

• Regulatory Compliance: Suppliers must adhere to cGMP and ICH guidelines to ensure high-quality API production compatible with global regulatory standards.

• Future Outlook: Continued investments in manufacturing capacity and supplier diversification position Novartis to meet growing global demand for KISQALI.

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FAQs

1. Who are the key API suppliers for KISQALI?
   While Novartis does not publicly disclose all API suppliers, it relies on leading chemical companies such as BASF, Dow, Evonik, and specialty chemical providers for raw materials and intermediates necessary for ribociclib synthesis.

2. Does Novartis outsource any manufacturing processes for KISQALI?
   Yes. Novartis collaborates with Contract Manufacturing Organizations (CMOs) for API synthesis, formulation, and packaging, particularly in regions like India, to expand capacity and reduce reliance on single sources.

3. What measures are in place to ensure the supply chain resilience of KISQALI?
   Novartis employs supplier diversification, geographic spread of manufacturing facilities, and strategic inventory management to mitigate risks associated with raw material shortages and geopolitical disruptions.

4. Are there risks associated with raw material sourcing for KISQALI?
   Yes. Dependence on specific intermediates and reagents exposes the supply chain to risks like shortages, regulatory changes, or geopolitical instability. Diversified sourcing helps mitigate these vulnerabilities.

5. How does regulatory compliance impact KISQALI’s supply chain?
   Suppliers must meet strict cGMP standards and quality controls mandated by agencies such as the FDA and EMA. Non-compliance can lead to delays, recalls, or supply interruptions, emphasizing the importance of rigorous qualification and audits.

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References:

1. Novartis. (2022). KISQALI (ribociclib) Prescribing Information.
2. U.S. Food and Drug Administration (FDA). (2022). Drugs@FDA - KISQALI.
3. European Medicines Agency (EMA). (2022). KISQALI approval details.
4. Chemical supplier disclosures and industry reports (publically available).
5. Novartis Annual Reports 2021-2022.